RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer.

PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast.

Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mammographic breast density as measured by the Madena method at 3 weeks [ Designated as safety issue: No ]

Estimated Enrollment:

100

Study Start Date:

November 2004

Detailed Description:

OBJECTIVES:

Primary

Determine, preliminarily, the efficacy of neoadjuvant fulvestrant, in terms of molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis, and the epidermal growth factor pathway, in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast.

Secondary

Determine the toxicity profile of fulvestrant in these patients.

OUTLINE: This is a randomized, placebo-controlled, pilot, multicenter study. Patients are randomized to 1 of 4 treatment arms.

Arm I: Patients receive oral placebo once daily on days 1-21.

Arm II: Patients receive oral tamoxifen once daily on days 1-21.

Arm III: Patients receive fulvestrant intramuscularly (IM) on day 1.

Arm IV: Patients receive fulvestrant IM as in arm III but at a higher dose. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo surgical resection of the tumor on approximately day 21.

PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study.

Eligibility

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed ductal carcinoma in situ (DCIS) of the breast

No underlying medical, psychiatric, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

More than 6 months since prior hormonal therapy, including any of the following:

Antiestrogens

Estrogen

Selective estrogen-receptor modulators

Progestins

Aromatase inhibitors

Radiotherapy

Not specified

Surgery

Not specified

Other

No prior therapy for DCIS

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126464